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Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy (r-PVB-1)

5 mei 2026 bijgewerkt door: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University

Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.

Revised-Paravertebral Nerve Block (r-PVB) is performed right after induction of general anesthesia and before lateral positioning of surgery. Under ultrasound guidance, an intercostal space between the 6th and 8th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block. Traditional Paravertebral Nerve Block (PVB) is performed right after the lateral positioning of surgery under ultrasound guidance. According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches. Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the 6th and 8th transverse processes, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space. Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement. Stop advancing the needle when the tip passes through the superior costotransverse ligament. Administer 2% lidocaine in pulsatile injections, 1-2 ml per pulse, observing the spread of fluid at the needle tip on ultrasound and depression of the pleura. Repeat pulsatile injections until a total of 5 ml lidocaine is administered, and if necessary, increase with another 5 ml of pulsatile lidocaine. The fluid movement and pleura depression observed on ultrasound confirm proper needle placement. Then, use this needle to inject 30 ml of 0.5% ropivacaine to complete the PVB. The surgical procedure will start right after the intervention blocks.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases

Exclusion Criteria:

  • Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics
  • Surgeon-estimated high likelihood of conversion to open surgery
  • Chronic opioid use
  • Heart failure, liver failure, or renal failure
  • Coagulation disorders
  • History of allergy to local anesthetics
  • Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: r-PVB
Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.
Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery. Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
Ander: PVB
Control
Paravertebral Nerve Block (PVB), the control of investigated intervention, is performed right after the lateral positioning of surgery under ultrasound guidance. According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches. Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the transverse process, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space. Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement. Stop advancing the needle when the tip passes through the superior costotransverse ligament.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean postoperative NRS pain score during the first 2 postoperative days
Tijdsspanne: From post-anesthesia care unit through postoperative day 2
Postoperative pain will be assessed using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine). The primary pain outcome is the mean of 8 postoperative NRS pain scores collected in the post-anesthesia care unit, on the evening of surgery, and on postoperative days 1 and 2 (morning, midday, and evening).
From post-anesthesia care unit through postoperative day 2
Mean QoR-15 score on postoperative days 1 and 2
Tijdsspanne: Postoperative day 1 and postoperative day 2
Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best). The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.
Postoperative day 1 and postoperative day 2

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative opioid and analgesic consumption
Tijdsspanne: Postoperative day 1 and postoperative day 2
Postoperative opioid and other analgesic consumption will be recorded and compared between groups. Opioid use will be converted to oral morphine equivalents where appropriate.
Postoperative day 1 and postoperative day 2
Postoperative complications
Tijdsspanne: From surgery through postoperative day 30
Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
From surgery through postoperative day 30
Length of postoperative hospital stay
Tijdsspanne: From surgery through postoperative day 30
Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
From surgery through postoperative day 30
Patient satisfaction with analgesia
Tijdsspanne: Postoperative day 2
Patient satisfaction with postoperative analgesia will be assessed using a 5-point scale ranging from very dissatisfied to very satisfied.
Postoperative day 2
Resting and movement NRS pain scores on postoperative days 1 and 2
Tijdsspanne: Postoperative day 1 and postoperative day 2
Resting and movement-related pain will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2.
Postoperative day 1 and postoperative day 2
Proportion of participants with pain score 4 or greater
Tijdsspanne: Postoperative day 1 and postoperative day 2
The proportion of participants with clinically significant pain, defined as the Numerical Rating Scale (NRS, 0-10) of 4 or greater, will be compared between groups.
Postoperative day 1 and postoperative day 2

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of local anesthetic systemic toxicity
Tijdsspanne: From intervention through postoperative day 30
The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
From intervention through postoperative day 30
Morbidity within 30 days after surgery
Tijdsspanne: From surgery through postoperative day 30
Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
From surgery through postoperative day 30
Readmission within 30 days after surgery
Tijdsspanne: From surgery through postoperative day 30
Hospital readmission within 30 days after surgery will be recorded and compared between groups.
From surgery through postoperative day 30
Pain scores at 30 days after surgery
Tijdsspanne: Postoperative day 30
Resting and movement-related pain at 30 days after surgery will be assessed using the Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
Postoperative day 30
QoR-15 score at 30 days after surgery
Tijdsspanne: Postoperative day 30
Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
Postoperative day 30

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

6 mei 2026

Primaire voltooiing (Geschat)

30 april 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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